# K103375: Plumepen Integrated Smoke Evacuation Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Medtek Devices, Inc.
- Decided: Mar 16, 2011 after 120 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K936304 (1994). 3 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954088: Telescoping Penevac, I.C Medical, Inc. (1995) Summary page 1.
- K000904: Penadapt 10, Buffalo Filter Co., Inc. (2000) Summary page 1.
- K936304: Electrosurgical Pencil, E & M Engineering, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K081634: Conmed Goldvac Integrated Smoke Evacuation Pencil, Conmed Corporation (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K120454: Safeair Smoke Pencil, (2012), 8 descendants of its own
- K142538: LiNA SafeAir Smoke Pencil (2014), 5 descendants of its own
- K182772: Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil (2018), 4 descendants of its own
- K143145: SafeAir Smoke Pencil (2014), 4 descendants of its own
- K153679: Stryker Neptune E-SEP Smoke Evacuation Pencil (2016), 3 descendants of its own

## Indications for use
The PLUMEPEN is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indications for use for PLUMEPEN® Integrated Smoke Evacuation Pencil include: a. To remove smoke plume from the surgical site b. To remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect

Source page: https://510kreport.com/device/K103375
Methodology: https://510kreport.com/methodology